CE marking

CE marking is a requirement of the European Union when introducing medical devices, personal protective equipment and in vitro diagnostic medical devices into the European Union. CE marking is a procedure for conformity with a specific directive or regulation, which can be completed by a manufacturer’s declaration or by the assessment of a notified body depending on the risk class of the prod

Before placing on the market

In order to place a product on the market within the European Union, a number of requirements must be met, which are set out in European directives or regulations. The detailed requirements appear already at the design stage, through production, quality control and product registration.

Verification of qualification and classification

Correct qualification and classification of a medical device is crucial for the determination of an appropriate conformity assessment procedure and allows to avoid legal complications and additional costs.

Analysis of harmonised standards

Identifying and performing the necessary tests in accordance with harmonised standards allows you to assess whether the product is effective and safe for use.

Risk management and analysis

In order to place a product on the market, the risks associated with the products must be identified, assessed and evaluated, and the effectiveness of the risk management process must be monitored.

Clinical trials of medical devices

Clinical trials of medical devices confirm that the products are designed and manufactured in accordance with legal requirements.

Clinical evaluation

Clinical evaluation is the procedure for collecting, evaluating and analysing clinical data on a medical device to verify that the clinical evidence proves the safety and effectiveness of the medical device.

Preparation of the technical documentation

Properly prepared technical documentation ensures compliance with the overall safety and performance requirements of the medical device.

Verification of the technical documentation

Verification that the technical documentation is prepared in accordance with the applicable law is an important step before starting the certification or notification process.

Selection and contact a notified body

A key step is the selection of a notified body that is suitable to certify the manufacturer's products for: classification, specific codes and conformity assessment procedure.

Product registration CA | EUDAMED

Prior to placing a medical device or in vitro diagnostic medical device on the market, a registration or notification must be made with the relevant Competent Authority or EUDAMED.

Medical device labeling

Labeling plays a crucial role in the conformity assessment process, as well as in the identification and traceability of medical devices on the EU market.

Performance evaluation of IVDs

Performance evaluation of in vitro diagnostic medical devices (IVDs) involves assessing the accuracy, reliability, and performance characteristics of IVD devices to ensure their suitability for clinical use. It is a critical step in the certification and regulatory approval process.

Regulatory strategy medical devices

The regulatory strategy of a medical device is a key element of the medical device design process, guiding the entire development process from design to EU market launch.

Usability studies medical devices

Usability in medical devices is a process that aims to design a medical device in such a way that it is easy and intuitive to use, the interface is tailored to the user and its use provides the highest possible level of effectiveness and safety.

After placing on the market

Following successful completion of the product conformity assessment process, the Manufacturer shall ensure that the surveillance and control activities for the manufacture of the devices, as well as the related post-market surveillance and observation activities, are carried out in a manner consistent with the current legal status.

Post market surveillance PMS

As part of market surveillance, procedures should be established and regularly updated to actively collect and review the post-marketing experience gained.

Vigilance

Vigilance consists of identifying medical incidents and events and carrying out corrective actions related to device safety.

Certificate of free sale

The certificate of free sale is a document facilitating the export of medical devices and in vitro diagnostic medical devices outside the European Union.

Significant change assessment

Significant change assessment in the line with the MDCG 2020-3 guidance and transitional provision under article 120 of the MDR 2017/745.

Other services

We offer a full range of support in the conformity assessment process and after its completion. We guarantee effectiveness in action in individual cases, adapted to the type of activity and manufactured products.

Personal protective equipment (PPE)

Personal protective equipment is a product that protects users from mechanical injuries.

Virtual Manufacturer Consulting

New MDR/IVDR regulations make it mandatory to have full technical documentation for all devices and to comply with manufacturer requirements, regardless of whether it is an OBL or OEM manufacturer.

Innovative medical devices

Innovative products require the development of an assessment towards meeting regulatory requirements and scientific evaluation to ensure patients have access to innovative, safe and effective medical devices.

Borderline products – medical devices & medicinal substance

Borderline cases are those for which it is not clear from the beginning whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not. The correct qualification and classification is crucial to assess if it falls within MDR IVDR or other regulations.